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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00322114
Date of registration: 03/05/2006
Primary sponsor: University of Illinois
Public title: Lycopene in Preventing Prostate Cancer in Healthy Participants
Scientific title: Mechanism of Prostate Cancer Prevention by Lycopene
Date of first enrolment: February 2006
Target sample size: 150
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00322114
Study type:  Interventional
Study design:  Allocation: Randomized, Primary Purpose: Prevention  
Countries of recruitment
United States
Contacts
Name:   Clinical Trial Office - University of Illinois Cancer Center
Address: 
Telephone: 312-355-3046
Email:
Affiliation: 
Name:   Richard B. van Breemen, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Illinois
Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS:

- Healthy participants

- No existing prostate disease

PATIENT CHARACTERISTICS:

- Able to supply blood and urine samples

- Able to answer demographic and dietary recall questionnaires

- No hospital inpatients

- Not allergic to tomatoes or tomato products

- Not abusing alcohol or non-prescribed drugs

- No existing gastrointestinal disease or cancer

PRIOR CONCURRENT THERAPY:

- At least 2 weeks since prior lycopene (in supplement form)

- No concurrent participation in another clinical trial



Age minimum: 18 Years
Age maximum: N/A
Gender: Male
Health Condition(s) or Problem(s) studied
Prostate Cancer
Intervention(s)
Dietary Supplement: lycopene
Other: placebo
Primary Outcome(s)
Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene [Time Frame: No]
Secondary Outcome(s)
Secondary ID(s)
CDR0000468031
UIC-2004-0217
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
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